Marques Carlos J, Daniel Sandra, Sufi-Siavach Anusch, Lampe Frank
Research Center of the Orthopedic and Joint Replacement Department, Schoen Klinik Hamburg Eilbek, Dehnhaide 120, 22081, Hamburg, Germany,
Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1660-8. doi: 10.1007/s00167-014-3127-x. Epub 2014 Jun 15.
The theoretical advantages of mobile-bearing (MB) designs over the conventional fixed bearings (FBs) for total knee arthroplasty (TKA) have not been proved yet through clinical studies. The aim of the study was to test whether the MB design has advantages in terms of better clinical outcomes when compared to FB. Furthermore, the relationships between intra-operative obtained implant positioning data and the clinical scores were analysed.
A total of 99 patients were randomized into the FB or the MB group. All patients received the same posterior cruciate retaining implants and were operated with the use of a computer-assisted navigation system. The clinical outcomes of both groups were compared pre-operatively, at 1 year, and at a mean follow-up time of 4 years after surgery.
The MB implants showed no advantages over the FB when comparing the Knee Society Scores, the Oxford Score, the range of movement (ROM) and pain intensity of the patients in both groups at 1 and 4 years after surgery. There were no relationships between the computer navigation data and the clinical scores.
In view of the 4-year results, there is no evidence to support the recommendation of one design over the other in terms of better clinical outcome scores, higher ROM or lower pain rates. Long-term follow-up results may be necessary, including survival rates. Further research comparing different TKA designs should also include standardized performance-based tests.
Prospective study (Randomized controlled trial with adequate statistical power to detect differences), Level I.
全膝关节置换术(TKA)中,活动平台(MB)设计相对于传统固定平台(FB)在理论上的优势尚未通过临床研究得到证实。本研究的目的是测试与FB相比,MB设计在临床结果方面是否具有优势。此外,还分析了术中获得的植入物定位数据与临床评分之间的关系。
总共99例患者被随机分为FB组或MB组。所有患者均接受相同的后交叉韧带保留型植入物,并使用计算机辅助导航系统进行手术。比较两组患者术前、术后1年以及术后平均4年的临床结果。
在比较两组患者术后1年和4年的膝关节协会评分、牛津评分、活动范围(ROM)和疼痛强度时,MB植入物相对于FB并无优势。计算机导航数据与临床评分之间没有关系。
鉴于4年的研究结果,没有证据支持在更好的临床结果评分、更高的ROM或更低的疼痛率方面推荐一种设计优于另一种设计。可能需要长期随访结果,包括生存率。比较不同TKA设计的进一步研究还应包括基于性能的标准化测试。
前瞻性研究(具有足够统计效力以检测差异的随机对照试验),I级。